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Abridged Prescribing Data

Septanest 1:100,000
SEPTANEST 1 :100,000. COMPOSITION: Articaine Hydrochloride 4%, Adrenaline (INN epinephrine) tartrate expressed as base 1100,000. THERAPEUTIC INDICATIONS: Local or loco-regional dental anaesthesia in patients of at least 4 years in case of classic or muco-gingival operations or dental surgical procedures where bone removal is necessary. DOSAGE AND ADMINISTRATION: For most common operations, one infiltration with 1.7 ml is sufficient. Do not exceed the equivalent of 7 mg articaine hydrochloride per kilo of weight. Dosage in children should be commensurate with their weight The recommended dose in 20 kg child is about % cartridge of 1.7 ml or)!2 cartridge of 2.2 ml and in 40 kg child is about 1.5 cartridge of 1.7 ml or 1 cartridge of 2.2 ml. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: Hypersensitivity to any local anaesthetic agent or any component of SEPTANEST. Do not use SEPTANEST in patients who have experienced bronchospasms after administration of products containing sulphites, patients with deficiency in plasma cholinesterase activity, patients receiving MAOI or tricyclic anti-depressants, patients in whom general anaesthesia might be required to complete the procedure and in children under 4 years of age SPECIAL WARNINGS: SEPTANEST should be used with caution in patients with hepatic disease, thyrotoxicosis, cardiovascular disease, abnormalities of cardiac conduction, epilepsy, and in diabetic patients. Intra-vascular injection is strictly contra-indicated. Resuscitative equipment, anti-convulsant medicines and other resuscitative drugs should be available for immediate use. The product should only be used in pregnancy when the benefits are considered to outweigh the risks. Breast feeding should be avoided for 48 hours after use of SEPTANEST. ABILITY TO DRIVE AND USE MACHINES: No demonstrated effects upon motor coordination, however subjects who suffer adverse effects should not drive or use machines until symptoms have resolved. INTERACTIONS: SEPTANEST should be administered with caution to any patient receiving drugs with sympathomimetic properties or with agents whose therapeutic actions may be antagonised by adrenaline. Articaine should be given with caution in patients receiving an antiarrhythmic agent UNDESIRABLE EFFECTS: Hypersensitivity, over dosage or intra-vascular injection may result in excitatory or depressant manifestations of the CNS, depressant cardio-vascular reactions, respiratory and allergic reactions .. Patients with peripheral or hypertensive vascular disease may develop ischemic injury or necrosis. PHARMACEUTICAL PRECAUTIONS: Store in the original container, below 25°C. Protect from light PHARMACEUTICAL FORM: Solution for injection contained in 1.7 and 2.2 ml dental cartridges LEGAL CATEGORY: POM.
FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LTD, Units R&S, Orchard Business Centre,
St Barnabas Close, Allington, Maidstone, Kent ME16 0JZ, UK. PL 08313/0039.

Septanest 1 :200,000
SEPTANEST 1 :200,000. COMPOSITION: Articaine Hydrochloride 4%, Adrenaline (INN: epinephrine) tartrate expressed as base 1200,000. THERAPEUTIC INDICATIONS: For dental anaesthesia only. Local or loco-regional dental anaesthesia in patients of at least 4 years in case of classic, or muco-gingival operations. DOSAGE AND ADMINISTRATION: For most common operations, one infiltration with 1.7 ml is sufficient Do not exceed the equivalent of 7 mg articaine hydrochloride per kilo of weight Dosage in children should be commensurate with their weight. The recommended dose in 20 kg child is about ¾ cartridge of 1.7 ml or ½ cartridge of 2.2 ml. and in 40 kg child is about 1.5 cartridge of 1.7 ml or 1 cartridge of 2.2 ml. CONTRA-INDICATlONS AND PRECAUTIONS FOR USE: Hypersensitivity to any local anaesthetic agent or any component of SEPTANEST. Do not use SEPTANEST in patients who have experienced bronchospasms after administration of products containing sulphites, patients with deficiency in plasma cholinesterase activity, patients receiving MAO I or tricyclic anti-depressants, patients in whom general anaesthesia might be required to complete the procedure and in children under 4 years of age. SPECIAL WARNINGS: SEPTANEST should be used with caution in patients with hepatic disease, thyrotoxicosis, cardiovascular disease, abnormalities of cardiac conduction, epilepsy, and in diabetic patients. Intra-vascular injection is strictly contra-indicated. Resuscitative equipment., anti-convulsant medicines and other resuscitative drugs should be available for immediate use. The product should only be used when the benefits are considered to outweigh the risks. Breast feeding should be avoided for 48 hours after use of SEPTANEST. ABILITY TO DRIVE AND USE MACHINES: No demonstrated effects upon motor coordination, however subjects who suffer adverse effects should not drive or use machines until symptoms have resolved. INTERACTIONS: SEPTANEST should be administered with caution to any patient receiving drugs with sympathomimetic properties or with agents whose therapeutic actions may be antagonised by adrenaline. Articaine should be given with caution in patients receiving an antiarrhythmic agent. UNDESIRABLE EFFECTS: Hypersensitivity, over dosage or intra-vascular injection may result in excitatory or depressant manifestations of the CNS, depressant cardio-vascular reactions, respiratory and allergic reactions. Patients with peripheral or hypertensive vascular disease may develop ischemic injury or necrosis. PHARMACEUTICAL PRECAUTIONS: Store in the original container below 25°C. Protect from light PHARMACEUTICAL FORM: Solution for injection contained in 1.7ml and 2.2 ml dental cartridges LEGAL CATEGORY: POM.
FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LTD, Units R&S, Orchard Business Centre,
St Barnabas Close, Allington, Maidstone, Kent ME16 OJZ, UK. PL 08313/0038

Lignospan
LlGNOSPAN SPECIAL 2%. COMPOSITION: Lidocaine Hydrochloride 2%, Adrenaline (Epinephrine) tartrate expressed as base 1 :80,000. THERAPEUTIC INDICATIONS: Local anaesthesia for dental procedures by infiltration or nerve block injections. DOSAGE AND ADMINISTRATION: Adults: 1 cartridge is generally sufficient. Do not exceed 3 cartridges. Adolescents between 14 and 17 and the elderly: usual dose 1.8 ml. Do not exceed 3.6 ml. Children between 6 and 14 usual dose 1.35 ml. Do not exceed 2.7 ml. Children between 3 and 6: 0.9 to 1.8 rnl. Do not use under 3 years of age. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: LlGNOSPAN SPECIAL is contra-indicated in patients with a known history of hypersensitivity to local anaesthetics of the amide-type or to any component of the injectable formulation. LlGNOSPAN SPECIAL due to the presence of a vasoconstrictor (adrenaline) in the formula is contra-indicated in patients suffering from: arterial hypertension, coronary disease, vascular cardiac disease (particularly sequelae to acute rheumatic fever). SPECIAL WARNINGS: for professional dental use only. Lignospan Special should be used with caution in patients with peripheral vascular disease or hepatic disease. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. Caution should be exercised when the product is administered during early pregnancy or to nursing women. Do not inject into a blood vessel. Aspiration should be performed before injection. Inject slowly. Local anaesthetic procedures should be used with caution where there is inflammation and/or sepsis in the region of injection. The lowest dosage that results in effective anaesthesia should be used. The cartridge should be used on one patient during one session of treatment only. INTERACTIONS: Avoid concurrent use with MAOI, tricyclic antidepressants or phenothiazines. Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Reduce doses of anaesthetic solution if sedatives are employed. Concurrent use of beta-adrenergic blocking agents may result in hypertension and bradycardia UNDESIRABLE EFFECTS: Hypersensitivity, over dosage or diminished tolerance may result in: excitatory or depressant manifestations of the central nervous system, depressant cardiovascular manifestations and allergic reactions. PHARMACEUTICAL PRECAUTIONS: Store in the original package, in a dry place below 25°C and protect from light. Do not freeze. PHARMACEUTICAL FORM: Solution for injection contained in 1.8 and 2.2 ml
dental cartridges LEGAL CATEGORY: POM.
FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LIMITED, Units R&S, Orchard Business Centre, St Barnabas Close, Allington, Maidstone, Kent ME16 OJZ, UK. PL 08313/0019.

Scandonest 2% Special
SCANDONEST 2% SPECIAL. COMPOSITION: Mepivacaine hydrochloride 2%, Adrenaline (Epinephrine) base 1/100,000. THERAPEUTIC INDICATIONS: Local anaesthesia for dental procedures by infiltration or nerve block injections DOSAGE AND ADMINISTRATION: Adults: 1 cartridge for routine work. Do not exceed 3 cartridges. Children Age 6 to 14 usual dose 1.6 ml. Do not exceed 3.3 ml. Age 3 to 6 1.1 to 2.2 ml. Do not use under 3 years of age. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: SCANOONEST 2% SPECIAL is contra-indicated in
patients presenting allergy to amide type anaesthetics or to any component of the formulation. SCANOONEST 2% SPECIAL due to the presence of a vasoconstrictor (adrenaline), is contra-indicated in patients suffering from: arterial hypertension, coronary disease, valvular affection or under MAOI or tricyclic anti-depressant treatment. SPECIAL WARNINGS: For professional dental use only. Should be used with caution in patients with peripheral vascular disease, hepatic disease, renal disease, a history of disturbances of cardiac rhythm or heart block, epilepsy or impaired respiratory function. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. Caution should be exercised when the product is administered during early pregnancy or to nursing women. Do not inject into a blood vessel. Aspiration should be performed before injection. Inject slowly. Local anaesthetic procedures should be used with caution where there is sepsis and/or inflammation in the region of infection. The lowest dosage that results in effective anaesthesia should be used. The product should not be injected repeatedly at the same site. The cartridge should be used on one patient during one session of treatment only. INTERACTIONS: Avoid concurrent use with phenothiazines, vasopressor drugs and ergot-type oxytocic drugs, beta-adrenergic drugs and chloroform, halothane, cyclopropane, trichloroethylene, or other related agents. Reduce doses of anaesthetic solution if sedatives are employed UNDESIRABLE EFFECTS: Hypersensitivity, over dosage or diminished tolerance may result in: excitatory or depressant manifestations of the central nervous system, depressant cardiovascular manifestations and allergic reactions. PHARMACEUTICAL PRECAUTIONS: Store in the original package, in a dry place below 25°C and protect from light. PHARMACEUTICAL FORM: Solution for injection contained in 1.8 and 2.2 ml dental cartridges. LEGAL CATEGORY: POM.
FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTOOONT LIMITED, Units R&S, Orchard Business Centre, St Barnabas Close, Allington, Maidstone, Kent ME16 OJZ, UK. PL 08313/0026

Scandonest 3% Plain
SCANDONEST 3% PLAIN. COMPOSITION: Mepivacaine hydrochloride 3%. THERAPEUTIC INDICATIONS: local anaesthesia for dental and chiropody procedures DOSAGE AND ADMINISTRATION: - in dentistry: Adults 1 cartridge for routine work. Do not exceed 3 cartridges. Children from 4 years of age and older: recommended dose: 0.025 ml/ kg body weight. Do not exceed 0.1 ml/ kg body weight - in chiropody Adults 2.2 to 4 ml. Do not exceed 4.4 ml/ digit and 6 mg / kg body weight /24h. CONTRA-INDICATIONS AND PRECAUTIONS FOR USE: SCANDONEST 3% PLAIN is contra-indicated in patients presenting specific allergy to amide type anaesthetics. SPECIAL WARNINGS: For professional dental use only. Should be used with caution in patients with hepatic disease, renal disease or a history of disturbances of cardiac rhythm or heart block. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. Caution should be exercised when the product is administered during early pregnancy or to nursing women. Do not inject into a blood vessel. Aspiration should be performed before injection. Inject slowly. Local anaesthetic procedures should be used with caution where there is sepsis and/or inflammation in the region of infection. The lowest dosage that results in effective anaesthesia should be used. The cartridge should be used on one patient during one session of treatment only. INTERACTIONS: Reduce doses of anaesthetic solution if sedatives are employed. UNDESIRABLE EFFECTS: Hypersensitivity, overdosage or diminished tolerance may result in: excitatory or depressant manifestalions of the central nervous system, depressant cardiovascular manifestations and allergic reactions. PHARMACEUTICAL PRECAUTIONS: Store in the original package, in a dry place below 25°C and protect from light. PHARMACEUTICAL FORM: Solution for injection contained in 1.8 and 2.2 ml dental cartridges. LEGAL CATEGORY: POM.
FOR FURTHER INFORMATION CONTACT THE PRODUCT LICENCE HOLDER: SEPTODONT LIMITED, Units R&S, Orchard Business Centre, St Barnabas Close, Allington, Maidstone, Kent ME16 OJZ, UK. PL 08313/0023.